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Project VerioVue Enhancements - Neonate Study

NCT06052371 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2023-12-27

No results posted yet for this study

Summary

The goal of this performance evaluation is to compare the blood glucose results obtained using the VerioVue Blood Glucose Monitoring system (BGMS) with those obtained from a validated comparator method (iSTAT 1 Analyser) using blood obtained from neonates. The main question it aims to answer is:

•How accurate is the VerioVue BGMS when compared to a product that has already been confirmed as accurate (iSTAT 1 Analyser) when hospital staff test blood taken from neonates on these instruments? Participants (neonates) will have a small amount of blood taken from a heel prick (performed by a HCP for medical purposes) or from an existing arterial line.

Conditions

Interventions

DEVICE

VerioVue (Enhancements) blood glucose monitoring system

VerioVue meter with expanded haematocrit range

Sponsors & Collaborators

  • LifeScan Scotland Ltd

    lead INDUSTRY

Principal Investigators

  • Nicola Zammitt, MBCHB · Edinburgh Centre for Endocrinology and Diabetes

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052371 on ClinicalTrials.gov